A New Reporting Guideline for Social and Psychological Intervention Trials: Consort-SPI

Problem: Many interventions in prevention science and related fields are complex.
Understanding randomized controlled trials (RCTs) of these complex interventions
requires detailed reports of the interventions tested and the methods used to evaluate
them. However, RCT reports often omit important information, hindering proper
critical appraisal and the effective transfer of this research evidence to policy and
practice decision-making. A new reporting guideline is needed to address this issue in
prevention science research.

Objective: To discuss a new extension of the Consolidated Standards of Reporting
Trials (CONSORT) Statement for social and psychological interventions:
CONSORT-SPI.

Procedure and Participants: Two sequential consultation studies are being
conducted to develop the CONSORT-SPI guidelines. Firstly, an online, modified
Delphi process included participants (n = 384) from 32 countries--researchers, practitioners, journal editors, funders, policy-makers,  practitioners, and client representatives--in the area of social and psychological
intervention. Participants were asked to rate the importance of including proposed
reporting standards in the CONSORT-SPI guidelines and to comment on their views
on the proposed items as well. The results of the Delphi process, along with previous
systematic literature reviews, were used to inform the second consultation study—a
formal consensus development conference in March 2014. At this meeting, 32
international stakeholders in social and psychological intervention research
discussed each recommended reporting standard and voted on the final guideline content. Recruited participants for this consensus meeting included key researchers, journal  editors, and funders in the area of social and psychological interventions.

Results: The CONSORT-SPI checklist of reporting standards pertains to the
essential content of the Title, Abstract, Introduction, Methods, Results, and
Discussion sections of all reports of social and psychological intervention RCTs.
Items in this checklist are based on empirical evidence of and expert consensus
opinion about their importance to internal and external validity of intervention trials.
An explanation and elaboration (E&E) document will provide detailed advice for each
reporting item, as well as examples of good reporting from trials in prevention science and
related disciplines.

Conclusions: This guideline is an important step toward improving reports of many
designs for evaluating social and psychological interventions. As demonstrated by
previous CONSORT guidelines, the development of an evidence-based reporting
guideline for social and psychological intervention RCTs should improve the
accuracy, comprehensiveness, and transparency of study reports. This, in turn,
promises to improve the critical appraisal of research and its use in policy and
practice decision-making. Endorsement of the guideline by journals, research funders,
and professional organizations will facilitate use of and feedback on the guideline,
which in turn will help to raise the quality of standards in this research area. We invite
readers to stay informed about the project by visiting our website
(http://tinyurl.com/CONSORT-study).